This clinical investigation is first of all designed to demonstrate the safety and effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in patients with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries. Secondary endpoints are the procedural success, patency at all follow-ups, late lumen loss and limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated. Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate its effectiveness and safety.

The lesion is pre-dilated with the PLEON EXPLORER balloon with a length of 10 mm or 15 mm or 20 mm under angiographic control. After dilation, the stenosed area is treated by one AMS implant. If the implanted stent is not fully apposed to the vessel wall or if initial angiography reveals a residual stenosis, the stent may be post-dilated with the delivery system balloon. If necessary, a high-pressure, non-compliant balloon catheter may be used.

Active Comparator: 2

PTA alone

Device: PLEON EXPLORER (Biotronik AG)

The lesion is dilated with the PLEON EXPLORER balloon with lengths of 10 mm or 15 mm or 20 mm, respectively. In case that the PTA procedure results in a residual stenosis of >50%, the AMS implant should be used to improve the result. A flow-limiting dissection does not qualify for stenting. Best effort must be made to obtain a satisfactory result (e.g. multiple and prolonged inflations) before a patient in the PTA group can be treated with a stent.

A maximum of two lesions in one infrapopliteal vessel treated within the study, or in two vessels of two different legs. (PTA treatment of other infrapopliteal lesions in non-study vessels is allowed outside the study).

Symptomatic critical limb ischemia (Rutherford 4, 5)

The patient must be ≥ 50 years.

Life-expectancy of more than 6 months

The subject or legal guardian has been informed of the nature of the study; agrees to its provisions and has signed informed consent

The patient must be available for the appropriate follow-up times for the duration of the study

The patient is capable to follow all study requirements.

Exclusion Criteria:

Patient refusing treatment

The reference segment diameter is not suitable for available stent design

Length of lesion requires more than one stent implantation

Previously implanted stent(s) or PTA at the same lesion site

Lesion lies within or adjacent to an aneurysm

Inflow-limiting arterial lesions left untreated

The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.

The patient takes Phenprocoumon (Marcumar).

The patient has a history of prior life-threatening contrast media reaction.

The patient is currently enrolled in another investigational device or drug trial.

The patient is currently breast-feeding, pregnant or intends to become pregnant.

The patient is mentally ill or retarded.

The patient is liable for military or civilian service.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572494